Prescription medicine
Ixabepilone Brand names: Ixempra
Ixabepilone (Ixempra) is a prescription medicine with an FDA approval on record since 2007. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ixabepilone FDA label on DailyMed (effective December 4, 2025, R-Pharm US Operating, LLC); the NDA 22065 record on Drugs@FDA; every ixabepilone label on DailyMed.
Highlights of the record
FDA label of December 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT.
IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )]. WARNING: TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT See full prescribing information for complete boxed warning. IXEMPRA ® in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death.
Used for
From the label: indications and usageIXEMPRA is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- October 16, 2007 Ixempra Kit, R-Pharm Us Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,049 through July 30, 2026
What is ixabepilone used for?
From the label: indications and usageIXEMPRA is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting [see Clinical Studies ( 14 )]. […]
Conditions named in the indications of ixabepilone's FDA labels, with every medicine labeled for each:
Source: FDA drug label (IXEMPRA), R-Pharm US Operating, LLC, effective December 4, 2025 (SPL set 241f0b1e-8b95-470d-876f-bf1804daaf18), via openFDA; the full label on DailyMed
What does the patient leaflet for ixabepilone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about IXEMPRA?Your healthcare provider should do blood tests to check your liver function: before you begin receiving IXEMPRA as needed while you are receiving IXEMPRA If blood tests show that you have liver problems, do not receive injections of IXEMPRA along with the medicine capecitabine. Taking these two medicines together if you have liver problems increases your chance of serious problems. These include serious infection and death due to a very low white blood cell count (neutropenia).
From the patient leaflet: What should I avoid while receiving IXEMPRA?IXEMPRA contains alcohol. If you are dizzy or drowsy, avoid activities that may be dangerous, such as driving or operating machinery. Do not drink grapefruit juice during treatment with IXEMPRA. Drinking grapefruit juice may cause you to have too much IXEMPRA in your blood and lead to side effects.
Source: FDA drug label (IXEMPRA), R-Pharm US Operating, LLC, effective December 4, 2025 (SPL set 241f0b1e-8b95-470d-876f-bf1804daaf18), via openFDA; the full label on DailyMed
Is there a generic for ixabepilone (Ixempra)?
No generic ixabepilone is approved (Drugs@FDA, October 8, 2026).
- 2007 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ixabepilone label say about other medicines?
The ixabepilone label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name ixabepilone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Capecitabine | boxed warning | TOXICITY IN PATIENTS WITH HEPATIC IMPAIRMENT IXEMPRA in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )]. |
| Castor oil | contraindications | … of severe hypersensitivity to agents containing Cremophor ® EL or its derivatives (e.g., polyoxyethylated castor oil) [see Warnings and Precautions ( 5.4 )]. |
| Epinephrine | warnings and precautions | … hypersensitivity reaction occur, stop the infusion of IXEMPRA provide supportive treatment as clinically indicated (e.g.. epinephrine, corticosteriods). |
Other labels that name ixabepilone
Source: FDA drug label (IXEMPRA), R-Pharm US Operating, LLC, effective December 4, 2025 (SPL set 241f0b1e-8b95-470d-876f-bf1804daaf18), via openFDA; the full label on DailyMed
What do FAERS reports show for ixabepilone?
The FDA Adverse Event Reporting System holds 1,049 reports that list ixabepilone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 240 are coded as a death and 419 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ixabepilone?
12 other medicines are given the same way (intravenous) and in the same FDA class as ixabepilone or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Docetaxel | Breast cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer | 10 labelers | n/a | No current entry |
| Eribulin | Breast cancer | 14 labelers | n/a | No current entry |
| Trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as ixabepilone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ixabepilone
- 12 medicines for the same use
- Ixabepilone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other